Effect of Fiber Supplementation in Children With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01399892
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011

July 20, 2011
July 21, 2011
September 2008
May 2010   (final data collection date for primary outcome measure)
incidence of hypoglycemia after fiber supplementation [ Time Frame: continuous glucose monitoring over 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01399892 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Fiber Supplementation in Children With Type 1 Diabetes
Effects of Fiber Supplementation on Glycemic Excursions and Incidence of Hypoglycemia in Children With Type 1 Diabetes

High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. They also appear to have a beneficial effect on cholesterol levels. It has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. The American Diabetes Association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. It is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. The investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. This will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Dietary Supplement: soluble fiber in the form of benefiber
Benefiber, sugar free in an amount to total 20gms/1000kcal/day of fiber
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The inclusion criteria are: Diagnosis of type I diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan.

Exclusion Criteria:

  • The exclusion criteria are: Medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home.
Both
4 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01399892
08-002142
No
Aida Lteif, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Aida N Lteif, MD Mayo Clinic
Mayo Clinic
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP